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About Alzamend Neuro Inc (ALZN)
Alzamend Neuro Inc is a clinical-stage biopharmaceutical company dedicated to developing innovative solutions for the treatment of neurodegenerative diseases and psychiatric disorders. The company's mission is to bring relief to the millions of individuals suffering from debilitating conditions such as Alzheimer’s disease, bipolar disorder, major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). By focusing on these critical areas, Alzamend aims to address significant unmet medical needs in the healthcare industry.
Core Technologies and Pipeline
Alzamend Neuro’s current pipeline comprises two groundbreaking therapeutic drug candidates:
- AL001: A patented ionic cocrystal technology that delivers lithium through a unique therapeutic combination of lithium, proline, and salicylate. This innovative approach seeks to enhance lithium delivery while minimizing side effects, potentially offering a safer and more effective treatment option for bipolar disorder, MDD, and PTSD.
- ALZN002: A patented method utilizing a mutant-peptide sensitized cell as a cell-based therapeutic vaccine. This technology aims to restore the patient’s immune system's ability to combat Alzheimer’s disease by targeting the underlying immunological deficiencies associated with the condition.
These proprietary technologies reflect Alzamend Neuro’s commitment to leveraging cutting-edge science to develop transformative therapies.
Market and Industry Context
Alzamend operates within the highly specialized biopharmaceutical sector, focusing on neurodegenerative and psychiatric disorders—areas with significant clinical and societal impact. Alzheimer’s disease alone affects millions worldwide, with limited treatment options currently available. By targeting this underserved market, Alzamend positions itself as a potential game-changer in the space. The company’s focus on psychiatric disorders further broadens its market potential, addressing conditions that collectively impact tens of millions globally.
Challenges and Differentiation
As a clinical-stage company, Alzamend faces challenges typical of the biopharmaceutical industry, including high R&D costs, lengthy clinical trials, and stringent regulatory requirements. However, its proprietary technologies and focus on innovative delivery mechanisms provide key differentiators. The company’s approach to lithium delivery through AL001 and its immunological vaccine strategy with ALZN002 set it apart from traditional treatment methodologies, potentially offering safer and more effective solutions.
Commitment to Innovation and Impact
Alzamend Neuro’s mission-driven approach underscores its dedication to improving patient outcomes and addressing critical gaps in treatment. By focusing on both neurodegenerative and psychiatric disorders, the company aims to make a profound impact on public health, providing hope to millions of individuals and their families.
Alzamend Neuro has achieved a significant milestone by dosing the first group of participants in a six-month Phase I comparative study for AL001, aimed at treating dementia related to Alzheimer's disease. This study will assess the safety and pharmacokinetics of AL001 compared to conventional lithium treatments, involving at least 24 healthy participants. The company believes AL001 could offer significant improvements over existing therapies for the over 40 million Americans suffering from Alzheimer's.
Alzamend Neuro, Inc. (Nasdaq: ALZN) announced a partnership with Altasciences to conduct a six-month Phase I clinical study for AL001, aimed at treating dementia related to Alzheimer’s disease. The study, commencing in September 2021, will evaluate the pharmacokinetics of AL001 compared to a marketed lithium carbonate capsule. AL001 utilizes patented ionic cocrystal technology designed to enhance lithium delivery. Alzamend believes this formulation may significantly improve treatment options for Alzheimer’s and other neurodegenerative diseases, reducing potential regulatory burdens.
Alzamend Neuro, Inc. (Nasdaq: ALZN) announced an additional investment from Digital Power Lending, LLC, totaling $2 million for 1,333,333 shares at $1.50 each. This funding follows the FDA's approval for a Phase 1a study of AL001, a lithium-based therapy for Alzheimer's-related dementia. As part of a March 2021 agreement, further capital will be provided based on future milestones. CEO Stephan Jackman expressed gratitude for the support, indicating that the funding positions Alzamend well for advancing clinical trials without needing new capital.
Alzamend Neuro (Nasdaq: ALZN) has submitted a pre-IND meeting request to the FDA for AL002, a cell-based therapeutic vaccine aimed at combating Alzheimer’s by restoring the immune system's ability to fight the disease. Recent toxicology results have been positive, leading to plans for a Phase 1 clinical trial at Emory University School of Medicine to assess the treatment's safety and efficacy. This trial will enroll patients with early-stage Alzheimer’s for a year, including an interim statistical analysis after six months.
Alzamend Neuro (Nasdaq: ALZN) has received a favorable FDA study may proceed letter for its AL001 oral therapy aimed at treating dementia related to Alzheimer's disease. This Phase 1 trial is expected to commence in September 2021. AL001 utilizes a patented lithium-based ionic cocrystal technology, which has shown promising preclinical results, enhancing cognitive function and reducing behavioral issues in mice compared to traditional lithium treatments. The company’s pipeline also includes AL002, another innovative Alzheimer's treatment.
Alzamend Neuro, Inc. (Nasdaq: ALZN) announced positive results from a GLP toxicology study of its product AL002, aimed at treating Alzheimer’s disease. Conducted on a transgenic mouse model, the study showed no significant toxicity, with no treatment-related mortalities or adverse effects noted. CEO Stephan Jackman stated that these results are a critical milestone, as the company prepares to submit a Pre-Investigational New Drug Application for AL002 to the FDA. Alzamend aims to develop innovative treatments for neurodegenerative diseases at an affordable cost.
Alzamend Neuro (Nasdaq: ALZN) celebrates its recent Nasdaq listing by ringing the opening bell on July 12, 2021. The event is led by CEO Stephan Jackman and Chairman William B. Horne, marking a significant milestone for stockholders and the ongoing fight against Alzheimer’s disease. Alzamend has raised approximately $14.4 million through its IPO, which will fund operations and clinical trials. The company is advancing its therapeutic candidate, AL001, and aims to develop innovative treatments for Alzheimer's and other neurodegenerative diseases.
Ault Global Holdings announced that Alzamend Neuro submitted an IND application to the FDA for a Phase 1 clinical study of AL001, a lithium-based therapy for Alzheimer's-related dementia. This IND marks a significant step in Alzamend's pipeline development. Following this study, Alzamend plans a Phase 1/2a trial to assess safety and effectiveness. With over 47 million people affected by dementia globally, the economic burden is immense, costing the U.S. approximately $355 billion in 2021 alone. Ault holds 5.3 million shares of Alzamend, showing a strong commitment to the development of treatments for neurodegenerative diseases.
Alzamend Neuro (Nasdaq: ALZN) has submitted an investigational new drug (IND) application to the FDA for the Phase 1 clinical study of AL001, a lithium-based therapy for Alzheimer's related dementia. The initial study aims to assess safe dosing, followed by a Phase 1/2a trial to evaluate safety and preliminary efficacy. Alzamend believes AL001 may enhance current lithium treatments. Preclinical data suggests it improves cognitive function compared to lithium carbonate treatments. The economic impact of Alzheimer's is significant, with high lifetime care costs.
Alzamend Neuro has successfully closed its initial public offering (IPO) of 2,500,000 shares, plus a full exercise of the underwriter's over-allotment option resulting in a total of 2,875,000 shares priced at $5.00 per share. The gross proceeds from the offering are approximately $14.4 million. This funding will support Alzamend's mission to develop treatments for neurodegenerative diseases and psychiatric disorders, including Alzheimer's Disease. The company operates with exclusive worldwide licenses for its product candidates from the University of South Florida Research Foundation.
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